Follicular extraction method and device

ABSTRACT

A method and device for the extraction of follicular units from a donor area on a patient. The method includes scoring the outer skin layers with a sharp punch, and then inserting a blunt punch into the incision to separate the hair follicle from the surrounding tissue and fatty layer. The method and device will significantly decrease the amount of follicular transection and increase the rate at which follicular units can be extracted.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 60/560,397 entitled FOLLICULAR EXTRACTION METHOD AND DEVICE, filedon Apr. 8, 2004, and U.S. Provisional Application Ser. No. 60/591,786entitled FOLLICULAR EXTRACTION. METHOD AND DEVICE, filed on Jul. 28,2004. The disclosure of each of these applications is incorporatedherein by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a method and device for the extractionof hair grafts from the donor area of a patient for subsequenttransplantation to a recipient area. More specifically, the presentinvention relates to a method and device for the extraction offollicular hair units that decreases the follicular transection rate andimproves the yield of transplantable follicular units.

2. Description of Related Art

The basic process of hair transplantation is to remove hair from theside and back fringe areas (donor areas) of the patient's head, and moveit to the bald area (recipient area). Historically, 4 mm diameter plugswere utilized as the donor plug; this was followed by mini-grafts(smaller plugs), and finally by follicular units grafts (FUG's). FUG'sare naturally occurring aggregates of 3-5 closely spaced hair follicles.The FUG's are distributed randomly over the surface of the scalp.

In the foregoing processes, a linear portion of the scalp is removedfrom the donor area by dissection with a scalpel. Some follicles areinvariably transected during this process, damaging the follicles. Inaddition to some follicular damage, the removal of this donor strip willalways result in a scar. In addition to the scar, there is usually adegree of moderate pain for several days and a sensation of tightnessfor 6-8 weeks following the procedure. Multiple procedures will resultin multiple scars and thinning of the hair above and below the scar. Ifthe pliability or laxity of the scalp is miscalculated, and a strip thatis too wide is removed, this procedure has the potential to create awide, unsightly scar because of the tension required to close the wound.Sometimes the resulting scar can be difficult to hide or disguise,causing a significant cosmetic deformity.

FUG's are dissected from a donor strip by several technicians usingoperating microscopes. Often the best technicians can produceapproximately 250 to 300 grafts per hour, and an average technicianproduces closer to 200 grafts per hour. The FUG's are sorted into groupsbased upon the number of hairs contained in the FUG. The besttechnicians will have a transection rate of from about 2% to 5%.

Recently, Dr. William Rassman and Dr. Robert Bernstein disclosed atechnique, called follicular unit extraction (FUE), whereby follicularunits were extracted from the donor area without the need to create alinear incision with a scalpel. This was accomplished by using a sharp 1mm diameter punch to make an incision into the epidermis and dermis, andthen removing the follicular unit from the surrounding skin withforceps. Their findings suggested that some follicles were easilyremoved; others had a significant tendency to shear in the process. Bytheir research, a good candidate was defined as one who experienced lessthan 20% shearing, and only about 25% of the patients tested wereconsidered good candidates by their shearing test. This test is calledthe FOX (FOllicular extraction) test.

The foregoing procedure is technically difficult, as the penetrationdepth and penetration angle is difficult to control. If the sharp punchpenetrates too deeply or at the incorrect angle there is a good chanceof transecting the follicular unit. This method has not been widelyadopted due to the problems of transection, difficulty removing thegrafts, the time required to produce the grafts, and the low percentageof potential candidates

Dr. John Cole, an expert in FUE, devised a device that limits the depthof the sharp punch to just below the attachment of the arrector pilimuscle (presumably responsible for tethering the FUG to the deepertissues and causing shearing during extraction), and increases thenumber of viable grafts produced. He has called his procedure the FIT,or Follicular Isolation Technique. He reports on his website that he hasproduced and transplanted up to 1200 grafts in one day. It is notbelieved that the time required to accomplish this has been moreaccurately reported.

The dissection of grafts from the scalps of African Americans and thosewith a high percentage of gray or white hairs is particularlyproblematic. The African American's follicles typically have a highdegree of curl or curve, making the dissection difficult and prone tohigh transection rates. The follicles of white or gray hair are all butinvisible, even under the microscope, making them prone to a high rateof transection as well.

There remains a need for a follicular extraction method and relateddevice that reduces the amount of follicular transection and increasesthe follicular extraction rate.

BRIEF SUMMARY OF THE INVENTION

To address the problems associated with standard follicular unitproduction and the current FUE methodology, the present inventionprovides a method and device to diminish or even eliminate theshortcomings of the existing technology. The method and device can beused by the uninitiated with a degree of success similar to a trainedindividual.

The method of the present invention first involves the use of a sharpscoring punch to score (incise) the skin to a limited depth of fromabout 0.3 mm to about 1.5 mm. As used herein, the term sharp is definedas having the capability to cut or incise the skin surface with relativeease by virtue of a thin keen edge. The scoring punch can have adiameter of, for example, about 1 mm (inner diameter). The scoring punchis then removed. Incising to this limited depth drastically reduces therisk of transecting the follicles because of the geometry of thefollicle and the limited depth of the incision. This scoring step isfollowed by the placement of a blunt punch, referred to herein as the“dissecting” punch, into the incision created by the scoring punch. Asused herein, blunt is defined as having a dull or rounded edge and beingunable to easily cut or incise by virtue of the dull edge. Thedissecting punch can have an inside diameter of about 1 mm and can havea length of from about 4 mm to about 6 mm.

The dissecting punch can be rotated slightly and pushed into the skin.Typically the operator feels a “popping” sensation as the leading edgeof the dissecting punch goes past the more dense tissues. The graft(follicular unit) formed by the foregoing steps is then removed from theskin, such as with forceps. The blunt aspect of the dissecting punchadvantageously reduces transection of follicles preferably to less than10%, by guiding the group of follicles into the lumen of the punchwithout shearing the follicles.

A device is also provided according to the present invention tofacilitate the implementation of the foregoing method. In oneembodiment, the device includes at least two basic components. Onecomponent is a sharp scoring punch preferably having an inner diameterof from about 0.7 mm to 1.0 mm but may be smaller or larger, that ishoused in a device that limits the depth of insertion, such as to fromabout 0.3 mm to about 1.5 mm. Once the incision is made, a bluntdissecting punch is activated by a slide mechanism and is inserted intothe incision and through the remainder of the skin, without advancingthe scoring punch. The blunt dissecting punch can have an insidediameter that is fractionally larger than the outside diameter of thescoring punch.

According to one aspect, the device can include a mechanism to rotatethe scoring and dissecting punches without the need to rotate the entireinstrument. According to another aspect, a mechanism is included to movethe dissecting punch rapidly through the skin layers. According to yetanother aspect, a component is included in the device to remove thegraft from the skin after the dissecting punch has performed itsfunction.

According to one aspect, the device is a “powered” device utilizing apower source selected from the group of electricity (AC or DC), air(pneumatic), suction, or mechanical power. The powered deviceadvantageously enables the mechanization of the scoring and dissectingfunctions, thereby relieving stress on the operator.

According to another embodiment, the device includes an elongate handlehaving a dissecting punch and a scoring punch disposed at opposite endsof the handle.

The method and device according to the present invention can providevalue to both the patient and physician. Some of the benefits are asfollows:

Patient Benefits

-   -   Reduce follicular transection, thus extracting more hair to        transplant    -   Increase donor capability by 50% to 80% (no longer limited by        scalp laxity)    -   Decrease post-operative pain    -   Speed healing    -   No visible scarring    -   Possible faster graft growth    -   African American and gray haired patients will benefit        significantly from less follicle damage

Physician Benefits

-   -   Decrease follicular transection    -   More exact planning for the number of grafts required.    -   Ability to select certain FUG's (i.e., more 4 hair FUG's than 2        hair FUG's to create density or more 1 hair FUG's for the        visible hairline)    -   Decrease number of staff (FUG's can be obtained by physician        alone, or by minimal number of qualified staff after limited        training)    -   The ability to obtain grafts from African American and gray        haired patients with confidence and minimal transection    -   The possibility of decreasing overhead and need for technical        equipment (e.g., microscopes for graft dissection)    -   The possibility of decreasing the price per graft and enlarge        the potential market    -   Marketing advantages to physicians offering superior patient        outcomes from advanced technology and instrumentation

These and other advantages of the present invention will become apparentto those of ordinary skill in the art upon consideration of thefollowing description of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a follicular extraction method according to the priorart.

FIG. 2 illustrates a follicular extraction method according to anembodiment of the present invention.

FIG. 3 illustrates a follicular extraction device and method accordingto an embodiment of the present invention.

FIG. 4 illustrates a follicular extraction device and method accordingto an embodiment of the present invention.

FIG. 5 illustrates a follicular extraction device and method accordingto an embodiment of the present invention.

FIG. 6 illustrates the dissecting punch of a follicular extractiondevice according to an embodiment of the present invention.

FIG. 7 illustrates a perspective view of a follicular extraction deviceaccording to an embodiment of the present invention.

FIG. 8 illustrates close-up perspective view of a blunt dissecting punchaccording to an embodiment of the present invention.

DESCRIPTION OF THE INVENTION

FIG. 1 schematically illustrates a follicular extraction techniqueaccording to the prior art, as developed by Dr. William Rassman and Dr.Robert Bernstein. See, for example, Rassman et al., Dermatologic Surgery2002; 28:720-728. Referring to FIG. 1(a), the patient's skin includes afatty layer 102, a dermis layer 104, and an epidermis layer 106. Withina donor area, a follicular unit 108 consisting of two hair follicles 110and 112 extends through the dermis 104 and epidermis 106 layers and isanchored in the fatty layer 102. It will be appreciated by those skilledin the art that follicular unit can include more or less than two hairfollicles.

During this follicular extraction technique, the operator aligns a sharppunch 114 substantially parallel with the protruding hairs, and thepunch 114 is pushed into the skin with sufficient force such that thesharp edge of the punch 114 extends downwardly through the epidermis 106and dermis 104 layers (FIG. 1(b). However, as is illustrated in FIG.1(c), the hair follicles 110 and 112 are transected by the punch 114 ifthe hair follicles are not substantially parallel through the layers.The operator then removes the follicular unit 116 (FIGS. 1(d), 1(e), and1(f)) using forceps 109 or a similar device. However, the removedfollicular unit 116 is severed and is not useful for transplantation(FIG. 1(f)).

FIG. 2 illustrates a follicular extraction method according to thepresent invention. Generally, the method of the present inventionincludes a two-step technique for the preparation of the follicular unitfor extraction. The first step scores the skin surrounding thefollicular unit and the second step separates the follicular unit fromthe surrounding tissue and fat in the form of a follicular unit plugwithout shearing the hair follicles.

Referring to FIG. 2(a), the patient's skin includes a fatty layer 202,dermis 204, epidermis 206, and a follicular unit 208. The follicularunit consists of two hair follicles, 210 and 212, extending through thedermis and epidermis, and anchored in the fatty layer 202.

The method of the present invention includes the use of a sharp scoringpunch 214 (FIG. 2(b)). The sharp scoring punch 214 includes a cuttingedge that is preferably circular in cross-section and preferably has aninner diameter of at least about 0.1 mm and not greater than about 1.1mm. According to one embodiment, the cutting edge of the scoring punch214 has an inner diameter of from about 0.7 mm to about 1.0 mm. Thecutting edge of the scoring punch has a sufficient sharpness to cutthrough the epidermis 206, dermis 204 and fatty layer 202 with relativeease, as is known to those skilled in the art. An example is the 1 mmDermal Biopsy Punch available from Miltex, Inc., Bethpage, N.Y.

The operator aligns the sharp scoring punch 214 approximately parallelto the hairs 210 and 212 protruding from the epidermis 206 with theprotruding hairs being disposed within the lumen of the scoring punch214. The operator then applies a limited amount of force to the scoringpunch 214 such that the scoring punch cuts through the epidermis 206 andscores (partially cuts through) the upper dermis 204, preferably to atotal depth of not greater than about 1.5 mm, such as from about 0.3 mmto about 1.5 mm. The sharp scoring punch 214 should be inserted to adepth sufficient to score the skin and upper dermis but not so deep asto risk transection of the follicles. The sharp scoring punch 214 isthen removed.

As is illustrated by FIG. 2(c), a blunt dissecting punch 215 that isless sharp than the scoring punch is then placed into the scoredincision created by the scoring punch 214. The blunt dissecting punch215 has an inner diameter that is fractionally larger than the outerdiameter of the scoring punch 214, whereby the dissecting punch 215 canreadily advance through the incision created by the scoring punch 214.The blunt dissecting punch 215 is less sharp than the scoring punch 214,and the leading edge of the dissecting punch 215 is such that theprobability of shearing a hair follicle (e.g., hair follicle 210) isvery low. However, the dissecting punch 215 is capable of advancingthrough the softer dermis 204 and fatty layer 202 without overduepressure being applied by the operator.

The dissecting punch 215 is advanced through the dermis 204 and thefatty layer 202 to a depth that is sufficient to enable the subsequentremoval of the follicular unit 208 in the form of a follicular unit plug(i.e., the follicular unit and immediate surrounding tissue) withoutsubstantially damaging the follicular unit 208. Accordingly, thedissecting punch 215 penetrates to a depth that is deeper than theinsertion depth of the scoring punch 214 and can be fully insertedthrough the dermis layer 204 and into the fatty layer 202. According toone embodiment, the dissecting punch 215 is inserted to a total depth ofat least about 1.5 mm and not greater than about 8 mm, such as fromabout 4 mm to about 7 mm (FIG. 2(c)). In one embodiment, the dissectingpunch 215 is inserted to a depth of not greater than about 5 mm. Thisbluntly separates the fibrous attachments surrounding the follicularunit 208, leaving it attached only at its base 203 (FIG. 2(d)). Thesurgeon then removes the follicular unit 208 from the skin using forceps209, or a similar device. The follicular unit 208 is removed intact andis ready for implantation at a recipient site.

It will be appreciated by those of ordinary skill in the art that thescoring punch 214 and the dissecting punch 215 can be fabricated frommaterials normally used for such purposes, such as rigid or semi-rigidmaterials and the like, particularly metals. It is preferred that thecross-section of each of the scoring punch and the dissecting punch iscircular for a variety of reasons, including that a circularcross-section enables the operator to twist (rotate) the punch tofacilitate movement into and through the various skin layers. However,other cross-sections may be useful, such as the elliptical biopsy punchdisclosed by Yeh et al. in U.S. Pat. No. 5,183,053, which isincorporated herein by reference in its entirety.

It will be appreciated that the method of the present invention can becarried out utilizing two or more separate devices for the scoring stepand the dissecting step. That is, a first device having a sharp punchand a second device having a blunt punch can be used to dissect andextract the follicular unit.

However, in a preferred embodiment, the method is carried out using asingle device that incorporates both the sharp scoring punch and theblunt dissecting punch. For example, the device can include a sharppunch disposed at one end of a rigid handle and a dissecting blunt punchat the other end of the handle.

FIG. 3 illustrates such a device according to one embodiment of thepresent invention. The device includes a sharp scoring punch 314 forscoring the skin layers, as is described above. The sharp scoring punch314 can have an outer diameter as is described with respect to FIG. 2,and in one embodiment has an outer diameter of about 1 mm.

In the embodiment illustrated in FIG. 3, the sharp scoring punch 314 isdisposed within the lumen of an outer blunt dissecting punch 315. Theoperator aligns the device, specifically the scoring punch 314,approximately parallel to the hairs 310 and 312 protruding from theepidermis, such that the protruding hairs 310 and 312 are disposedwithin the lumen of the sharp scoring punch 314. The device, with thesharp scoring punch 314 extended, sharply cuts through the epidermis 306and scores the upper dermis 304, preferably to a total depth of notgreater than about 1.5 mm, such as from about 0.3 mm to about 1.5 mm,the depth of the incision preferably being limited by the device (FIG.3(a)). As is illustrated in FIG. 3, the incision depth of the scoringpunch 314 is limited by the end of the dissecting punch 315. The sharpscoring punch 314 is then retracted into the lumen of the dissectingpunch 315, and the dissecting punch 315 is advanced into the scorecreated by the scoring punch and through the dermis 304 and into thefatty layer 302, preferably to a depth as discussed above with respectto FIG. 2, such as from about 4 mm to about 7 mm (FIG. 3(b)). Theinsertion depth of the dissecting punch is also preferably limited tothe preferred depths disclosed herein by the device. As is illustratedin FIG. 3(b), the insertion depth of the dissecting punch is limited bythe end of the housing enclosing the scoring punch 314 and dissectingpunch 315. The housing can also serve as the handle of the device to begripped by the operator, as is illustrated in the embodiment of FIG. 5.

The action of the dissecting punch 315 bluntly separates the fibrousattachments surrounding the follicular unit 308, leaving it attachedonly at its base 303 (FIG. 3(c)). The operator then removes thefollicular unit 308 from the skin using forceps 309, or a similar device(FIGS. 3(d) and 3(e)), such as a tension device or a suction device, forexample. The follicular unit is then ready for implantation at therecipient site.

FIG. 4 illustrates a preferred embodiment of the present invention wherethe dissecting punch utilizes a serrated or “saw tooth” tip 401comprising a plurality of splines. This modification allows thedissecting punch to more readily separate the attachments of the dermisto the follicular unit and allow advancement through the tissues withgreater ease by using rotation, either manual rotation or automatedrotation. Any number of splines 402 can be utilized and in oneembodiment, the dissecting punch tip includes from 2 to 5 splines. Oneedge of the splines may be at an angle relative to the primary axis 404of the dissecting punch, as illustrated in FIGS. 4(b), 4(c), 4(d), 4(e)and 4(f), or straight (substantially parallel to the primary axis 404 ofthe dissecting punch) as illustrated in FIG. 4(g). FIG. 4(d) shows theexternal appearance of the dissecting punch while FIGS. 4(e) and 4(g)represent a cross section of this modified dissecting punch tip showinga scoring punch 408 extended and retracted respectively.

It should also be noted that according to one embodiment the scoringpunch and dissecting punch could be one in the same. More specifically,a single punch can include a number of splines that have a sharp leadingedge and are capable of scoring the skin when rotated in one direction,and having a blunt trailing edge that is capable of dissecting withouttransecting the hair follicles when the punch is rotated in the oppositedirection.

According to one embodiment, either a suction probe within the lumen ofthe device or mechanical forceps provide traction on the follicular unitin order to remove the follicular unit. Further, the device can includea mechanism for rotating the sharp scoring punch and/or dissecting punchas they are pressed into the patient's skin. Another embodiment includesa mechanism whereby a blade or biting scoop or dissecting wire isincorporated into the tip of the dissecting punch, and when activatedwill sever the fatty attachment at the base of the follicular unit toenhance the ease of plug removal from the surrounding skin. Thismodification may or may not include a method to remove the follicularunit in its entirety through the lumen of the device using mechanicalgrasping or suction application to the follicular unit, such as to movethe follicular unit to a chilled holding solution.

FIG. 5 illustrates a follicular extraction device according to anotherembodiment of the present invention. The device includes a rigid handle516, preferably made of medical grade plastic or other suitable materialthat can have a scored surface to promote the ease of handling. At oneend, the device includes a sharp scoring punch 514 shown incross-section for scoring the skin layers, as is described above. Thesharp scoring punch 514 can have an outer diameter as is described withrespect to FIG. 2, and in one embodiment has an outer diameter ofapproximately 1 mm. A blunt dissecting punch 509, shown incross-section, is provided at the other end of the device and preferablyhas an inner diameter of from about 0.8 mm to about 1.0 mm. The leadingedge of the dissecting punch 509 is less sharp than the scoring punch514 so that the probability of shearing a hair follicle is very low.

The user can align the device, specifically the scoring punch 514,approximately parallel to the hairs 510 and 512 protruding from theepidermis such that the protruding hairs are disposed within the lumenof the sharp scoring punch 514. The device, held between the fingers, isrotated about the axis of the handle and sharply cuts through theepidermis 506 and scores the upper dermis 504, preferably to a totaldepth of from about 0.3 mm to about 1.5 mm, the depth of the incisionpreferably being limited by the device. In the embodiment illustrated inFIG. 5, the depth is limited by a lower surface 517 of the handle 516.The device is then rotated or “twirled” between the operator's fingersso that the dissecting punch 509 is in position over the protrudinghairs 510 and the incised epidermis 506 and dermis 504. The dissectingpunch is then advanced through the dermis 504 and the fatty layer 502,preferably to a depth as discussed above with respect to FIG. 2, such asfrom about 4 mm to about 7 mm, the depth preferably being limited by thedevice. This action bluntly separates the fibrous attachmentssurrounding the follicular unit 508, leaving it attached only at itsbase 503. The tip of the dissecting punch can also be serrated, as isdescribed above and is illustrated in FIG. 4(f) and FIG. 4(g).

The operator can then remove the follicular unit 508 from the skin usingforceps 509, or a similar device. The follicular unit is then ready forimplantation at the recipient site. The process can be repeated multipletimes to affect the proper number of follicular unit extractions.

According to one preferred embodiment of the present invention, thedissecting punch is tapered (e.g., beveled) to ease insertion of thepunch into the scored skin. A cross-section of such a dissecting punchis illustrated in FIG. 6. The punch 600 includes a blunt dissecting tip602 and a shoulder 604 adapted to restrict the penetration depth of thepunch. The punch includes a tapered portion 606 to ease insertion of thepunch and to enhance the separation of the follicular unit from thesurrounding skin tissue. It will be appreciated that a taper can beapplied to a non-serrated punch as well as a serrated punch. Accordingto one embodiment, the length of the tapered portion (a) is at leastabout 0.3 mm and is not greater than about 0.7 mm. According to a morepreferred embodiment, the tapered portion has a length of at least about0.4 mm and not greater than 0.6 mm, such as about 0.5 mm. For efficientdissection, the tapered portion 606 preferably reduces the primaryoutside diameter by at least about 10% and not greater than about 30%,such as by about 20%. For example, in one embodiment the punch 600 has aprimary outer diameter (b) of about 1.52 mm and a tip diameter (c) ofabout 1.24 mm, where the total length of the dissecting punch (e.g., tothe shoulder 604) is about 5 mm and the inner diameter is about 1 mm.

FIG. 7 illustrates a perspective view of a follicular extraction device700 according to another embodiment of the present invention. The device700 includes an elongated handle 702 having a recessed mid-section 704adapted to be gripped by a user. A first end of the handle 702 comprisesa sharp scoring punch 706 adapted to score the epidermis and dermis ofthe patient. The device can then be flipped in the operator's hands andthe blunt dissecting punch 708 located at a second end of the handle 702can be used to dissect the follicular unit from the surrounding skintissue.

FIG. 8 illustrates a perspective view of the blunt dissecting punchillustrated in FIG. 7. The blunt dissecting punch 808 includes a taperedportion and is serrated to accommodate removal of the follicular unitfrom the surrounding skin tissue. As is illustrated in FIG. 8, the bluntdissecting punch includes 4 splines 810.

The foregoing illustrates some devices that are adapted to carry out themethod of the present invention. However, it will be appreciated bythose skilled in the art that the method can be carried out utilizingother devices.

EXAMPLES

The method of the present invention is carried out to perform follicularextraction on a number of patients. Testing includes patients withdemanding hair types, African Americans and those with gray hair, andthe results are substantially zero transaction on a limited number ofsamples. Extrapolation of timing trials using the method of the presentinvention reveals the ability to extract 300 to 400 grafts per hour.This rate of graft production may convey the ability to transplant up to2000 grafts per day. A device combining multiple components has thepotential to double this graft production rate and allow cases of up to3000 grafts per day.

The serrated dissecting punch according to the present invention canreduce the frequency of buried follicular units, a phenomenon where thedissecting punch pushes the follicular unit into the skin tissue. Inanother example, three patients are enrolled in a follicular extractionprocedure, receiving a total of 422 grafts. The method of the presentinvention is utilized wherein a sharp dissection of the epidermis ismade with a 1 mm punch (Miltex, Inc., Bethpage, N.Y.) to a depth ofabout 1.3 mm followed by the insertion of a blunt serrated dissectingpunch (similar to that illustrated in FIG. 8) to a depth of 5 mm. Thefollicular units are then removed with Foerster forceps. Folliculartransaction rates and the incidents of buried follicular units arerecorded.

The grafts represent a possible total of 1207 follicles, with 48follicles transected. This is a follicular transaction rate of 4percent. In this series of 422 extracted grafts, there are 4 buriedgrafts with 3 retrieved, representing a graft burial rate of 0.9% and anon-retrieval rate of 0.2%. The serrated tip allows for a more rapid andsmoother insertion process that enhances the dissection process.

While various embodiments of the present invention have been describedin detail, it is apparent that modifications and adaptations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and adaptations are withinthe spirit and scope of the present invention.

1. A method for the extraction of a follicular unit plug from a donorarea, comprising the steps of: (a) scoring a preselected portion of adonor area to form a scored incision having a first depth; (b) insertinga dissecting punch into the scored incision to a second depth that isgreater than said first depth and form a follicular unit plug comprisinga follicular unit; and (c) removing the follicular unit plug from thedonor area.
 2. A method as recited in claim 1, wherein said dissectingpunch is a blunt dissecting punch.
 3. A method as recited in claim 1,wherein said scored incision is substantially circular.
 4. A method asrecited in claim 3, wherein said scored incision has a diameter of fromabout 0.1 mm to about 1.1 mm.
 5. A method as recited in claim 3, whereinsaid scored incision has a diameter of from about 0.7 mm to about 1 mm.6. A method as recited in claim 1, wherein said first depth is notgreater than about 1.5 mm.
 7. A method as recited in claim 1, whereinsaid first depth is from about 0.3 mm to about 1.5 mm.
 8. A method asrecited in claim 1, wherein said second depth is from about 1.5 mm toabout 8 mm.
 9. A method as recited in claim 1, wherein said second depthis from about 4 mm to about 7 mm.
 10. A method as recited in claim 1,wherein said dissecting punch is removed from the donor area before saidstep of removing said follicular unit plug.
 11. A method as recited inclaim 1, wherein said step of removing said follicular unit plugcomprises removing the follicular unit plug using forceps.
 12. A methodas recited in claim 1, wherein said step of removing said follicularunit plug comprises using suction.
 13. A method as recited in claim 1,further comprising the step of separating a bottom portion of saidfollicular unit plug from the fatty layer before said removing step. 14.A method as recited in claim 1, wherein said step of inserting adissecting punch comprises rotating said dissecting punch about aprimary axis of said dissecting punch.
 15. A method as recited in claim1, further comprising the step of transplanting said follicular unit.16. A device for carrying out a method as recited in claim
 1. 17. Amethod for the extraction of a follicular unit plug from a donor area,comprising the steps of: (a) scoring a preselected portion of a donorarea to form a scored incision having a first depth of not greater thanabout 1.5 mm; (b) inserting a blunt dissecting punch into said scoredincision to a second depth of at least about 4 mm to form a follicularunit plug comprising a follicular unit; (c) removing said follicularunit plug from the donor area; and (d) transplanting said follicularunit plug in a recipient area.
 18. A device for the extraction of afollicular unit from a donor area, comprising: (a) a sharp scoringpunch; and (b) a blunt dissecting punch.
 19. A device as recited inclaim 18, wherein said scoring punch comprises a cutting edge that issubstantially circular.
 20. A device as recited in claim 19, whereinsaid cutting edge has an inner diameter of from about 0.1 mm to about1.1 mm.
 21. A device as recited in claim 19, wherein said cutting edgehas an inner diameter of from about 0.7 mm to about 1 mm.
 22. A deviceas recited in claim 18, wherein said device further comprises means forlimiting the depth of insertion of said scoring punch.
 23. A device asrecited in claim 22, wherein said means for inserting said scoring punchcomprises means for limiting the depth of insertion for said scoringpunch to not greater than about 1.5 mm.
 24. A device as recited in claim18, wherein said sharp scoring punch is disposed within a lumen of saidblunt dissecting punch.
 25. A device as recited in claim 18, whereinsaid device further comprises means for rotating said dissecting punch.26. A device as recited in claim 18, wherein said dissecting punchcomprises a serrated dissecting edge.
 27. A device as recited in claim18, wherein said dissecting punch further comprises means for separatinga bottom portion of said follicular unit plug from the fatty layer. 28.A device as recited in claim 18, wherein said dissecting punch istapered.
 29. A device as recited in claim 28, wherein said dissectingpunch is serrated.
 30. A device as recited in claim 18, wherein saidsharp scoring punch and said blunt dissecting punch are disposed atopposite ends of an elongated handle.
 31. A device for the extraction ofa follicular unit from a donor area, comprising: (a) a handle adapted tobe gripped by an operator and having first and second ends; (b) a sharpscoring punch disposed at said first end of said handle; and (c) adissecting punch disposed at said second end of said handle.
 32. Adevice as recited in claim 31, wherein said handle is adapted to limitthe incision depth of said scoring punch.
 33. A device as recited inclaim 31, wherein said scoring punch has an inner diameter of from about0.1 mm to about 1.1 mm.
 34. A device as recited in claim 31, whereinsaid scoring punch has a diameter of from about 0.7 mm to 1 mm.
 35. Adevice as recited in claim 31, wherein said dissecting punch isserrated.
 36. A device as recited in claim 31, wherein said dissectingpunch is tapered.
 37. A device as recited in claim 31, wherein saidhandle is adapted to limit the incision depth of said dissecting punch.38. A device for the extraction of a follicular unit from a donor area,comprising: (a) a handle adapted to be gripped by an operator; and (b) adual-function punch disposed at an end of said handle, saiddual-function punch comprising a round serrated tip having splines,wherein a leading edge of said splines is sharp and a trailing edge ofsaid splines is blunt.
 39. A device as recited in claim 38, wherein saiddevice further comprises means for rotating said dual-function punch intwo rotational directions about an axis of said punch.
 40. A deviceadapted for the separation of a scored follicular unit from thesurrounding tissue and fatty layer, comprising a blunt punch comprisinga lumen and comprising a plurality of blunt serrations at a first end ofsaid punch.
 41. A device as recited in claim 40, wherein said bluntpunch is tapered.